Kornimate/medical-research-clean huggingface dataset:
ventral or inguinal hernia, robotically repaired with ovitex mesh

Conditions: Hernia, Ventral; Hernia, Inguinal

Summary: this study is designed to evaluate the post-operative complications and hernia recurrence following the use of ovitex in subjects with ventral or inguinal hernias. up to 160 subjects will participate in the study from up to 20 investigator sites.

this study is intended to evaluate the post-operative complications and recurrence following the use of ovitex in ventral or inguinal hernias being treated robotically. it is a single-arm study and all subjects will receive ovitex.

Eligibility criteria:
inclusion criteria: 1. subject suffers from a ventral or inguinal hernia that requires surgical repair with the use of an implant to reinforce or replace weakened or missing tissue. 2. the patient is scheduled for an elective robotic approach with the use of ovitex lpr, ovitex core permanent, or ovitex 1s permanent. 3. the size of the implant needed for repair is expected to be less than or equal to 15 x 25 cm for ovitex lpr and 25 x 40 cm for ovitex core permanent and ovitex 1s permanent. 4. subject meets cdc/ssi wound classification class i (clean), class ii (clean-contaminated) or class iii (contaminated) criteria. 5. subject is willing and able to sign an informed consent for the study and has signed the irb approved informed consent form for this study. 6. subject is able to complete quality of life (qol) and pain questionnaires. 7. subject is at least 21 years old. 8. subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements. exclusion criteria at baseline: 1. subject has a bmi of \> 40 2. subject meets cdc/ssi wound classification class iv (dirty-infected) criteria 3. subject is female and is pregnant or plans to become pregnant during the course of the study. 4. subject has a life expectancy of \< 2 years making it unlikely that the subject will successfully achieve two-year follow-up. 5. subject has recent history of drug or alcohol abuse (in last 3 years). 6. subject has an allergy to ovine-derived products. 7. subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial. 8. subject has a strangulated hernia. exclusion criteria intraoperative: 1. subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision. 2. subject unable to receive ovitex lpr, ovitex core permanent, or ovitex 1s permanent time of surgery.

Keywords: use of mesh robotic hernia repair
comparison of viscoelastic measurement by rotem® delta and clotpro® in trauma patients.

Conditions: Polytrauma; Coagulation Disorder

Summary: the purpose of the study is to describe the differences and interchangeability in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.

the study will commence following the approval by the ethics research committee. all patients admitted to our emergency department for trauma from the 1st of october 2019 to the 31st of january 2020 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. informed consent will be requested. viscoelastic tests of coagulation will be performed on rotem® delta and clotpro® simultaneously. we will compare values of clotting time (ct), clot formation time (cft), alfa angle, maximum clot firmness (mcf) and maximum lysis (ml) for test of extrinsic pathway(ex-test) on clotpro® vs. test for extrinsic pathway (extem) on rotem® delta. further we will compare values of clotting time (ct), clot formation time (cft), alfa angle, maximum clot firmness (mcf) and maximum lysis (ml) for thromboelastometry of fibrinogen (fib-test) on clotpro® vs. thromboelastometry of fibrinogen (fibtem) on rotem® delta. the secondary outcome will be to describe the dependence of measurement on temperature of patient. study data will be entered in study form. the measurements can be repeated in time. the indication for next measurement is fully on treating physician. differences in estimated viscoelastic coagulation parameters and interchangeability of two devices will be analysed.

Eligibility criteria:
inclusion criteria: * age ≥18 years * polytrauma with injury severity score ≥ 16 exclusion criteria: * pregnancy * anticoagulant therapy * antiplatelet therapy * coagulation disorders

Keywords: polytrauma coagulopathy viscoelastic tests
impact of drains on postoperative nausea and vomiting after thyroid surgery

Conditions: Postoperative Nausea and Vomiting

Summary: wound drains after thyroid- and parathyroid surgery impact on postoperative nausea and vomiting (ponv)

postoperative nausea and vomiting (ponv) is common after thyroid surgery. many patients describe ponv as more irritant in the postoperative course than the endured pain. postoperative drains are put after thyroid surgery to early recognize bleeding and to collect wound secretion to avoid pressure on the trachea. whether wound drains do impact on ponv is not known. therefore, we tested the impact of wound drains on ponv after thyroid- and parathyroid surgery in a randomized controlled clinical trial.

Eligibility criteria:
inclusion criteria: * older than 18 years of age * informed consent * planed thyroid- or parathyroid resection * euthyreostatic preoperative condition exclusion criteria: * younger than 18 years of age * pregnancy * no informed consent * retrosternal struma * known postoperative nausea and vomiting prior to surgery * severe and life threatening systemic health issues

Keywords: ponv thyroid surgery nausea and vomiting postoperative
nebulized amikacin versus intravenous amikacin in the treatment of nosocomial pneumonia

Conditions: Pneumonia

Summary: the investigator's goal in this study is to evaluate the efficacy and safety of nebulized amikacin versus intravenous amikacin in patients with hospital and ventilator acquired pneumonia in surgical patients admitted to the intensive care units infected with gram negative bacilli

prospective, randomized, controlled study on post-cardiac surgery patients , included two groups, over one year period. the first group was administered intravenous (iv) amikacin 20 mg/kg once daily. the second group was prescribed amikacin nebulizer 400 mg twice daily. both groups were co-administered intravenous (iv) piperacillin/tazobactam empirically.

Eligibility criteria:
inclusion criteria: * patients admitted to icu * clinical suspicion of vap or hap defined by a new persistent radiological infiltrate and one of the following signs: * purulent tracheal aspirations, or * temperature of 38° or higher, or leucocyte count \> 10000/ml or * positive culture sensitive to amikacin * in case of empirical treatment, risk of multi resistant bacteria defined as follows: * antimicrobial therapy in preceding 90 days and * current hospitalization of 5 d or more exclusion criteria: * history of asthma * multi organ failure or any psychiatric illness * allergy to amikacin or intolerance to nebulized amikacin * myasthenia gravis. * severely impaired renal function (creatinine clearance lower than 10 ml/min or renal replacement therapy) * vestibulo-cochlear disease. * pregnancy. * brain death
boramae hospital liver cirrhosis patient cohort study

Conditions: Liver Cirrhosis; Hepatocellular Carcinoma

Summary: liver cirrhosis represents a worldwide health problem and is a major cause of mortality. cirrhosis is the common end for chronic alcohol abuse and hepatitis c and b virus infections. patients who have cirrhosis have varying degrees of compensated liver function, and clinicians need to differentiate between those who have stable, compensated cirrhosis and those who have decompensated cirrhosis. it is shown various complications: portal hypertension, hepatocellular carcinoma, hepato-renal syndrome, etc. thus, it is important to have this information to manage disease and determine specific therapy. however, register-based studies in have not been reported in korea. the goal of this study is to describe the natural history of a large number of patients with liver cirrhosis prospectively followed, and to identify predictors of the occurrence of hepatocellular carcinoma.

the investigators are planning to recruit patients with liver cirrhosis, and collect the baseline clinical laboratory data. biological tests, endoscopy,liver ultrasonography (including arfi) and hepatic venous pressure gradient measurements will be performed if not done within 90 days prior to inclusion. during this visit, 20 ml of blood will be collected for freezing and storage of serum and plasma, and constitution of a dna library. monitoring: patients will have regular surveillance with blood test, liver ultrasonography and medical consultation at least every 6 months, periodic assessment of esophageal, gastric varices and portal hypertensive gastropathy (every 1 year) and prevention of their rupture if any. an additional blood sampling of 20 ml will be taken at baseline and every year in order to perform whole blood, serum, plasma, peripheral blood mononuclear cells and dna libraries; data will be standardized and centralized in a single database. and alcoholic liver cirrhosis patients will undergo liver biopsy for polymerase chain reaction, western blot, immunohistochemistry and rna analysis. after measurement of hepatic venous pressure gradient and liver stiffness at baseline a non-selective beta-blocker (nsbb,carvedilol) was initiated and increased stepwise (weekly) until the systolic blood pressure remained at\>100 mmhg and the heart rate was not \ =20% compared to baseline or to an absolute value \<=12 mmhg. compliance with therapy was monitored by monitoring of heart rate and blood pressure during clinical visits.

Eligibility criteria:
inclusion criteria: * age ≥19years old proven cirrhosis * no previous hepatocellular carcinoma (treated or not) * signed informed consent exclusion criteria: * serious associated short-term life threatening disease (except associated hiv viral infection and the liver disease itself) * liver focal lesion suggestive of hepatocellular carcinoma * patient under guardianship * pregnant women * inability to regular monitoring, for whatever reason

Keywords: liver cirrhosis hepatocellular carcinoma
vertical ridge augmentation with autogenous onlay blocks combined with guided bone regeneration versus autogenous bone graft with titanium mesh in posterior mandible

Conditions: Posterior Mandible With Deficient Ridge Height

Summary: atrophic ridge augmentation utilizing guided bone regeneration (gbr) has become a major treatment option to provide optimal bone support for osseointegrated dental implants. gbr was initially employed to treat simple defects, including dehiscence and fenestration defects. in addition, gbr has been utilized for horizontal and vertical ridge augmentations and has demonstrated reproducible outcomes, with high implant survival rates and low complication rates. the results of recent clinical and histologic studies of ridge augmentation with gbr indicated that autogenous bone graft may be a suitable material for staged localized ridge augmentation in both horizontal and vertical augmentations. the main advantages of autogenous grafts are their osteogenic, osteoinductive and osteoconductive capabilities. because of these qualities, autogenous grafts are considered by many to be the gold standard for bone regeneration

the gbr procedure requires to place a barrier between the bone graft and the surrounding soft tissues. this blocks the fast-duplicating connective and epithelial cells from colonizing the regenerating site. collagen membranes have been successfully used as a barrier membrane in clinical practice. they have the advantage of being resorbable and pose less post-operative complications. on the other hand, collagen membranes are not rigid, causing a difficulty in maintaining the vertical height of the particulate bone graft placed onto the ridge. alternatively, titanium meshes have been used with success in clinical practice and display both advantages and disadvantages. they provide tenting effect thanks to their rigidity and, being moldable, can be easily given the shape needed to cover the defect. however they must be removed, not resorbable, require time-consuming shaping and pose complications as flap dehiscence. choice of the comparator: current studies have shown that using titanium mesh as a barrier to protect the bone graft during gbr can be considered successful in terms of vertical bone gain. there might be variable in other findings which could be attributed to differences in the methodology, such as using other membranes over the titanium mesh (collagen or ptfe membranes).

Eligibility criteria:
inclusion criteria: * adult patients with edentulous posterior mandible. * both sexes. * no intraoral soft and hard tissue pathology. * no systemic condition that contraindicate implant placement. * residual alveolar bone height more than 6 mm (7-9 mm) and less than 12 mm. exclusion criteria: * presence of fenestrations or dehiscence of the residual ridge. * heavy smokers more than 20 cigarettes per day. * patients with systemic disease that may affect normal healing. * psychiatric problems * disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
taste properties of hiv inhibitor

Conditions: HIV Infections

Summary: the purpose of the study is to assess the taste properties of hiv inhibitor


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * men and women of non-childbearing potential professional sensory panelists * aged between 25 and 80 years exclusion criteria: * history of relevant drug or food allergies, cardiovascular or central nervous system (cns) disease, clinically significant pathology, history of mental illness * positive hiv test
impact of obstructive sas on metastatic potential of cutaneous melanoma

Conditions: Melanoma With a Breslow's Thickness ≥ 1mm; Obstructive Sleep Apnea Syndrome

Summary: hypothesis: to address if diagnosis of obstructive sleep apnea before or during the extending check-up is a risk factor toward metastasis for melanoma stage ≥ tiian0m0 study design: adult patients with a breslow's thickness ≥ 1mm coming to the surgery consultation will have a nocturnal oximetry for screening of obstructive sleep apnea. patients having an abnormal nocturnal oximetry will be explored by polysomnography in order to detect sleep apnea syndrome. patients with sleep apnea will be treated. standard dermatologic follow-up over a 3 years period with thoraco-abdominal-pelvic and cerebral ct-scan and a lymph-node ultrasound every 6 months will be performed.

melanoma is a cutaneous cancer due to a proliferation of melanocytes. for metastatic cases the prognostic is poor (18% survival at 5 years). few factors predict metastasis. sleep apnea syndrome is involved in mechanism of carcinogenesis and aggressiveness markers of malignant cutaneous melanoma. hypothesis: to address if diagnosis of obstructive sleep apnea before or during the extending check-up is a risk factor toward metastasis for melanoma stage ≥ tiian0m0 study design: adult patients with a breslow's thickness ≥ 1mm coming to the surgery consultation will have a nocturnal oximetry for screening of obstructive sleep apnea. patients having an abnormal nocturnal oximetry will be explored by polysomnography in order to detect sleep apnea syndrome. patients with sleep apnea will be treated. standard dermatologic follow-up over a 3 years period with thoraco-abdominal-pelvic and cerebral ct-scan and a lymph-node ultrasound every 6 months will be performed. sample size: based on previous data from the investigators showing that 25% of patients with a breslow's thickness ≥ 1mm will have node or visceral metastasis. for an alpha threshold of 5% and a study power of 80%, with 5% of dropouts, with the hypothesis that 40% of apnea syndrome patients will metastasis versus 20% in the control group the study should include 83 patients in each group. statistical analysis: an intermediate analysis after 80 included patients will be performed. peto method will be followed, results will be considered significant with a p≤0.001 and the study will be stopped. normality of data will be checked by kurtosis and skewness tests, variance equality will be tested with the leven test. the significance level will be set at 5%.

Eligibility criteria:
inclusion criteria: * adults hospitalized in the dermatological unit for the initial consult for a melanoma with a breslow's thickness ≥ 1mm exclusion criteria: * pregnant women * institutionalized patient * patients with metastasis in the lymph node or any organ at the time of the first consult * patients with another neoplasia requiring treatment other than surgery in the last 5 years * patients with creatinine above 200µmol/ml or clearance below 30ml/min
program evaluating the autoimmune disease investigational drug ct-p13 in as patients(planetas)

Conditions: Ankylosing Spondylitis

Summary: this study is the trial to demonstrate how our product is similar to remicade by comparing the results of blood samples in active ankylosing spondylitis patients.


Eligibility criteria:
inclusion criteria: * diagnosed with active ankylosing spondylitis * basdai score ≥ 4 and visual analogue scale(vas) score of spinal pain ≥ 4 exclusion criteria: * have total ankylosing of spine * have allergies to infliximab * serious infection
open-label extension evaluating methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder

Conditions: Attention Deficit/Hyperactivity Disorder

Summary: this study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder


Eligibility criteria:
inclusion criteria: 1. completion of the 40-week core study crit124d2302 and week 40 (end of study) assessments or patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (premature discontinuation visit) exclusion criteria: 1. patients who, during the core study, developed any psychiatric condition that requires treatment with medication or that may interfere with study participation and /or study assessments. 2. patients who during the core study developed cardiovascular disorders. 3. pregnant women. 4. patients who developed seizures during the core study. 5. diagnosis of glaucoma, hyperthyroidism, pheochromocytoma. 6. diagnosis or family history of tourette's syndrome. 7. patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke other protocol-defined inclusion/exclusion criteria may apply

Keywords: attention deficit /hyperactivity disorder, hyperactivity
efficacy and safety of shr-1918 in patients with hyperlipidemia

Conditions: Hyperlipidemia

Summary: evaluation of the efficacy and safety of multiple subcutaneous injections of shr-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase ii clinical trials


Eligibility criteria:
inclusion criteria: 1. on the day of signing the informed consent form, the age must be ≥ 18 years old and ≤ 75 years old, both men and women are eligible; 2. screen spatiotemporal abdominal ldl-c for ascvd risk assessment, meeting the following conditions: 3. tg≤5.6mmol/l； exclusion criteria: 1. (1) alanine aminotransferase (alt), aspartate aminotransferase (ast), or gamma glutamyltransferase (ggt) exceeding 3 times the uln, or total bilirubin exceeding 2 times the uln; 2. (2) human immunodeficiency virus antibody (hiv ab), hepatitis c virus antibody (hcv ab), any of the above test results are positive; hepatitis b virus surface antigen (hbsag) positive and hbv-dna ≥ 1000 copies/ml (or ≥ 200iu/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200iu/ml, hbv-dna ≥ the lower limit of the detection value); 3. (3) creatine kinase (ck) exceeds 3 times the upper limit of normal value (uln); 4. (4) thyroid stimulating hormone (tsh) is below the lower limit of normal (lln) or exceeds 1.5 times the upper limit of normal (uln); 5. (5) glomerular filtration rate (egfr)\<30 ml/min/1.73m2 (calculated using the mdrd formula, egfr (ml/min/1.73m2)=175 x (serum creatinine/88.4) -1.234 x age -0.179 x (0.79 females), where serum creatinine units are μ mol/l);
can we reduce the number of vaccine injections for children?

Conditions: Invasive Meningococcal Disease

Summary: this open label randomised controlled study will evaluate the induction of immunity following varying schedules of vaccination with glyco-conjugate neisseria meningitidis serogroup c (menc) vaccines in infancy. 498 infants will be enrolled in this multi-centre trial. participants will receive either 0, 1, or 2 priming doses of a menc-crm197 conjugate vaccine or 1 priming dose of a menc-tt conjugate vaccine in the first year of life, with all groups receiving a dose of a combination hib-menc-tt vaccine at 12 months, as well as all other concurrent routine vaccinations. all groups will also be further divided into 2 groups to receive their routine vaccines in either consistent or alternating limbs to assess the immune response to the concurrent infant routine immunisations administered in consistent versus alternating limbs. immune responses will be assessed at 5, 12, 12months +6 days, 13 and 24 months of age.


Eligibility criteria:
inclusion criteria: * healthy male or female infants aged 6-12 weeks at the time of the first vaccination and who were born between 37 and 42 weeks of gestation * infants who are known to be free from medical problems as determined by a medical history and clinical examination * parents or guardians who are willing for their child to participate and who would be expected to comply with the requirements of the protocol * parents/guardians who have given informed consent for their child's participation in the study exclusion criteria: * history of invasive meningococcal c disease * previous vaccination against meningococcal serogroup c disease * planned administration/administration of vaccines, since birth, other than the study vaccines (with the exception of oral rotavirus vaccine, hepatitis b vaccine and bcg). * receipt of investigational vaccines/drugs, other than the vaccines used in the study, within 30 days prior to receiving the first dose of the vaccines or their planned use during the study period * confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * receipt of more than 2 weeks of immunosuppressants or immune modifying drugs, (e.g. prednisolone \>0.5mg/kg/day) * history of allergy to any component of the vaccines. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures * acute disease at the time of recruitment as defined by the presence of a moderate or severe illness with or without fever (with the exception of minor illnesses such as diarrhoea, mild upper respiratory infection without fever). in such situations enrolment should be postponed until the participant has recovered. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period * parents who plan to move out of the geographical area where the study would be conducted.

Keywords: meningococcal serogroup c vaccine conjugate